U-Lite
FDA 510(k) clearance K143601 · decided 2015-03-18
Clearance details
- K-number
- K143601
- Device name
- U-Lite
- Applicant
- Sonoscanner Sarl
- Decision
- Substantially Equivalent
- Date received
- 2014-12-18
- Decision date
- 2015-03-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Paris, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.